The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the World Health Organization (WHO) in March 2020. The SARS-COV-2 virus is easily transmissible and there is currently no approved treatment with effective results. Although the main epidemiological parameters are currently being studied, apparently the speed of contagion, the incidence and the mortality rate in severe cases appear to be high. Therefore, there is an urgent need to find a viable therapeutic option. The present trial is a pilot study with an objective to determine the efficacy of standard treatment reinforced with two repeated doses in two consecutive days of plasma from former convalescent people of the COVID-19 disease already discharged and / or with results in negative COVID-19 screenings, transfused to hospitalized COVID-19 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Convalescent plasma plus standard treatment for COVID-19. The convalescent plasma is from patients recovered from COVID-19 and negative viremia in the test detection COVID-19. The infusions will be given on days 1 and 2, of the study, after the positive result for COVID-19 of the recipient patient.
The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-Interleukin-6 monoclonal antibody, oxygen therapy, etc..)
University Hospital Son Llatzer
Palma de Mallorca, Islas de Balears, Spain
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.
Time frame: Day 7
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.
Time frame: Day 14
Anti-SARS-CoV-2 S IgG Serum Titer
The levels of Anti-SARS-CoV-2 S IgG serum
Time frame: At inclusion, Day 21
Time of Hospitalization
time that the patients have passed in the hospital.
Time frame: Day 21
Time to Negativization of RT-PCR
total time elapsed until negative RT-PCR test
Time frame: Day 21
Diastolic Blood Pressure
the pressure of blood in the artery when the heart relaxes between beats.
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Systolic Blood Pressure
The pressure of blood in the artery when the heart contracts. It is the high number in a blood pressure measurement.
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Temperature
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Cardiac Frequency
The number of heart contractions or beats per unit of time. The normal values in adults at rest range between 60 and 100 beats per minit.
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Respiratory Frequency
Number of breaths the patient takes per minute.
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Oxygen Saturation
blood oxygen percentage. A healthy percentage of oxygen in the blood is between 95% and 100%.
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Hemoglobin
hemoglobin levels in the blood
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Leucocytes
Leucocyte count a patient's blood.
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Neutrophils
Neutrophils count a patient's blood.
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Absolute Lymphocytes
lymphocyte count a patient's blood.
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Activated Partial Thromboplastin Time
measurement of the number of seconds it takes for a clot to form in a patient's blood.
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Fibrinogen Level
measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease.
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Fragment D-dimer Assessment
Determination of the existence of the D-dimer fragment in blood as a measure of assessing the severity of the disease.
Time frame: At inclusion, Day 3, Day 7, Day 14
Glomerular Filtration Rate Assessment
estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min).
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Troponin I Assessment
measurement of the levels of troponin I proteins in the blood (ng/mL), as a measure of assessing the severity of the disease.
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Procalcitonin Assessment
measurement of the levels of procalcitonin in the blood (ng/L), as a measure of assessing the severity of the disease.
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
C-reactive Protein Assessment
measurement of the level of c-reactive protein in the blood (mg/dl), as a measure of a change in inflammation
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Lactate Dehydrogenase (LDH) Assessment
measurement of the level of lactate dehydrogenase in the blood (U/L), as a measure of assessing the severity of the disease.
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Interleukin-6 Assessment
measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease.
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Ferritin Blood Assessment
measurement of the amount of ferritin (blood protein) in ng/ml in the blood, as a measure of assessing the severity of the disease.
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Percentage of Patients Requiring Admission to Intensive Care Units.
Percentage of patients requiring admission to intensive care units.
Time frame: Day 21
Mortality Rate at 15 Days
number of dead participants through day 15
Time frame: Day 15
Mortality Rate at 30 Days
number of dead participants through day 30
Time frame: Day 30
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